Takeda Pharmaceuticals Director, Nonclinical Regulatory Writer- Oncology in Des Moines, Iowa
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Director, Nonclinical Regulatory Writer in our Cambridge, MA office or remotely reporting to the Head of Nonclinical Regulatory Writing and Submissions (NRWS).
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
As a Director, Nonclinical Regulatory Writing, Oncology - Team Lead in the Nonclinical Regulatory Writing and Submissions (NRWS) group within Preclinical and Translational Sciences (PTS), you will be empowered to contribute to this science driven, collaborative and dynamic environment, bringing experience to add further value to the NRWS contribution to the PTS organization and to Takeda, with involvement in a variety of projects of diverse scope and complexity, reflecting the breadth of Takeda’s portfolio (e.g., Oncology). The NRWS team is a goal- and results-driven team, and we are strong believers in innovation and streamlined processes.
POSITION OBJECTIVES AND ACCOUNTABILITY:
Member of the Nonclinical Regulatory Writing and Submissions (NRWS) leadership who drives NRWS vision and mission.
Meet corporate goals by managing nonclinical regulatory writing activities with focus on Oncology outlined in the nonclinical development plans.
Work with NRWS Head to sets strategic vision and establish structure for the Oncology nonclinical writing team to successfully execute on high-quality deliverables across all programs.
Involve in a variety of projects of diverse scope and complexity, across all developmental stages (pre-development through post-marketing) with focus on Oncology therapeutic area.
Lead the planning, tracking, compilation, and regulatory compliance of nonclinical technical and regulatory components to support regulatory submissions.
Direct authoring or reviewing nonclinical sections of regulatory documents, such as Investigator's Brochures (IBs), Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologic License Applications (BLAs), Clinical Trial Applications (CTAs), Marketing Authorization Applications (MAAs), as well as nonclinical technical reports. Summarize pharmacology, pharmacokinetics and toxicology data and prepare briefing packages for regulatory agency meetings or advice and contribute to or prepare responses to requests for nonclinical information to worldwide health authorities.
Represent NRWS on cross-functional teams (Clinical, Global Patient Safety, Program Management, GRA, Regulatory Operations) to plan, generate, manage, and finalize nonclinical documents for regulatory submissions. Generate nonclinical timelines. Liaise effectively with cross-functional team members to communicate aims, content requirements, and timelines.
Work in close partnership with Global Regulatory Affairs (GRA) and nonclinical subject matter experts (SMEs) from pharmacology, drug metabolism and pharmacokinetics and modeling (DMPK&M), drug safety research and evaluation (DSRE), and other functions, as well as external collaborators.
Represent NRWS on internal and external cross-functional initiatives, as required.
Demonstrate and apply advanced knowledge of relevant regulatory requirements and corporate policies, as well as work experience, to assess document requirements and identify information gaps or other potential issues. Ensure nonclinical regulatory documents adhere to standards and regulatory guidelines.
Collaboration with the NRWS Nonclinical Technical and Regulatory writing team, GI sharing of knowledge and coordinating work practices as well as the sharing of resources, when appropriate.
Work closely with the NRWS Operations team to develop and maintain nonclinical writing processes, standards, and tools (e.g., SOPs, work instructions, templates, style guide, etc.), as well as coordinate and manage relevant contract nonclinical writers and outside vendors.
Drive and implement automation and innovation in the technical and regulatory writing framework in conjunction with the NRWS Systems and Innovation team.
Manages all Oncology team related internal staffing and performance management, including hiring, training, coaching and performance reviews. Lead or support training initiatives within the group and will support maintenance of a balanced workload among nonclinical writers.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
Ph.D. in scientific field (e.g., pharmacokinetics, pharmacology, toxicology), with minimum of 10 years of leadership experience with nonclinical and/or scientific writing within large pharmaceutical or Contract Research Organization (CRO) – MANDATORY
Experience in pharmaceutical or biotech product development across numerous modalities, with direct involvement in regulated studies related to pharmacology, toxicology, or pharmacokinetics, demonstrating a broad understanding of the drug development process.
Significant experience in direct authoring of nonclinical summary sections to support regulatory submissions, including but not limited to IBs, briefing books, INDs, periodic reports, NDAs/MAAs/BLAs, and agency responses – MANDATORY .
Experience with regulatory submissions for new modalities (e.g.: cell therapies) is an advantage.
Experienced manager with experience in a program management-type role; ability to prioritize, manage multiple programs within strict regulatory/compliance deadlines and lead internal/external and scientific teams to regulatory submission aims.
Thorough understanding of regulatory guidelines related to global submissions and submission content (e.g., FDA/EMA/PMDA regulations; ICH guidance and familiarity with GLP/GCP requirements).
Learn and understand new therapeutic areas quickly and comprehensively.
Possess innovative problem-solving skills and ability to influence peers.
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs
Base Salary Range: $156,80 0 to $224,000 . Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Massachusetts - Virtual
- Takeda Pharmaceuticals Jobs